ISM Innovation Specialist Amgen Technology Private Limited

8.0 - 13.0 years

1 - 8 Lacs

Hyderabad, Telangana, India

On-site

Key Activities Technology Scouting & Evaluation - Monitor and evaluate industry trends, emerging technologies, academic research, and vendor solutions related to AI/ML for post-market safety and product complaints surveillance. Maintain a landscape of external vendors offering signal detection, NLP, and data analytics solutions relevant to product surveillance. Collaboration & Innovation Development - Partner with the ISM Data Science team to assess feasibility, develop prototypes, and deploy AI/ML models for signal detection and augmentation of signal assessment Engage with stakeholders (e. g. , TA Safety) to identify unmet needs and prioritize use cases. Facilitate workshops or ideation se...

Posted 1 month ago

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Regulatory Affairs Specialist (Medical Devices) Siemens Healthineers

4.0 - 6.0 years

0 Lacs

Bengaluru, Karnataka, India

On-site

Do you want to contribute to the future of healthcare As Siemens Healthineers values those who dedicate their energy and passion to this cause, our companys name is dedicated to our employees. Its their pioneering spirit, blended with our long history of engineering in the ever-evolving healthcare industry that truly makes us unique as an employer. We offer you a flexible and dynamic environment and the space to stretch beyond your comfort zone to grow both personally and professionally. Sound interesting Then come in and join India team as Regulatory Affairs Specialist. Your tasks and responsibilities: Planning and preparing product related medical device submissions for the products manufa...

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QA RA Senior Specialist Adecco India Private Limited

5.0 - 10.0 years

5 - 10 Lacs

Bengaluru, Karnataka, India

On-site

Working knowledge of relevant global medical device regulations, requirements, and standards, such as ISO 13485, 21 CFR Parts 803, 806, and 820, ISO 14971, the European Medical Device Directive (93/42/EEC), and EU MDR (2017/745). Provide Quality and Regulatory Affairs input to the product development team and manage all QA & RA responsibilities throughout product development, design changes, and post-market surveillance processes. Establish and analyze key performance indicators to evaluate and continuously improve the Quality Management System (QMS). Possess broad experience and apply professional concepts and company objectives to resolve complex issues in creative and effective ways. Prov...

Posted 2 months ago

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